fMRI for BPS: A Descriptive Study of Findings and Symptoms

NCT06294951 | Recruiting

• 1 other identifier: IIT-2023-0225
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to investigate the relationship between functional magnetic resonance imaging (fMRI) findings of the brain and symptom presentation in patients with bladder pain syndrome (BPS). The main questions it aims to answer are:

1. 1.To explore the distribution characteristics of fMRI imaging and possible target lesions in the patient population.
2. 2.To provide appropriate clues and evidence for etiological exploration and therapeutic targeting of BPS.

Conditions

Bladder Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• fMRI findings

  The fMRI is acquired using a Siemens 3.0T MRI scanner. BOLD functional images are scanned using an echo planar imaging (EPI) sequence. The scanning parameters are: TR=2s, matrix size of 64\*64, number of layers=30, layer thickness=3.75\*3.75\*4.5mm, and bottom-up interval scanning. A total of 540 whole brain functional images are acquired. The relevant data acquired from fMRI should undergo the following pre-processing before generating findings: (1) data format conversion; (2) temporal layer correction; (3) head movement correction; (4) normalization; (5) smoothing

  1 day (fMRI is performed once upon the recruitment of the study subject.)

Study Arms (2)

BPS group

Patients with BPS (subject to current diagnostic criteria and clinical guidelines).

Diagnostic Test: fMRI

Control group

Patients with symptoms of bladder pain and evidence of current urinary tract infection.

Diagnostic Test: fMRI

Interventions

fMRI DIAGNOSTIC_TEST

The fMRI is acquired using a Siemens 3.0T MRI scanner. BOLD functional images are scanned using an echo planar imaging (EPI) sequence. The scanning parameters are: TR=2s, matrix size of 64\*64, number of layers=30, layer thickness=3.75\*3.75\*4.5mm, and bottom-up interval scanning. A total of 540 whole brain functional images are acquired.

BPS group; Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The groups or cohorts will be selected from Urology clinic of Renji Hospital, Shanghai Jiao Tong University School of Medicine

You may qualify if:

• Be 18 years of age or older and female;

You may not qualify if:

• Persistence of symptoms for more than 6 months;
• Visual analogue scale (VAS) of pain ≥ 4;
• O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) score of 12 or more, with pain and nocturia domain scores \>2;
• Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) \>13;
• No history of cystoscopy within 2 years.
• With proliferative cystoplasty or previous surgery or any pharmacological and non-pharmacological treatment for BPS;
• Pregnant or lactating women;
• Contraindications to MRI;
• Average urine output less than 40 ml or more than 400 ml;
• Haematuria (more than 1+ in urine dipstick test);
• Evidence of current urinary tract infection at the time of recruitment;
• Tuberculosis of the genitourinary system or cancer of the bladder or uroepithelial cancer;
• Recurrent urinary tract infection;
• History of hysterectomy, mid-urethral sling, pelvic organ prolapse repair, vaginal delivery or caesarean section, prostate surgery or treatment within 6 months;
• History of neurological disease such as cerebral infarction, multiple sclerosis, or Parkinson's disease;

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Zhebin Du, Dr.

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

• Yinghui Fan, Dr.

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhebin Du, Dr.

CONTACT

+86-13512179027; Dzbdzb1989@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 6, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

CN (1)